One Touch Ping Insulin Pump using ezManager Max diabetes management software
FDA device recall Z-1560-2010 · posted 2010-05-08 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software.
- Action taken
- The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 21 pumps
- Distribution
- The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA
- Date initiated
- 2009-12-18
- Date posted
- 2010-05-08
- Date terminated
- 2010-06-22
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |